Confirmation of the minutes of the 100th meeting held on Tuesday 30
September 2014

4

Declaration of conflicts of interest

5

Matters arising

5.1

At the 99th meeting on 1 July 2014, the Committee recommended that if the medicine Prochymal was not
used in New Zealand over the next two years its approval should lapse when the provisional consent expires on 14
June 2016.

Medsafe met with CARSL Consulting following this recommendation. The Committee will be provided with an update
on this meeting.

5.2

At the 100th meeting on 30 September 2014, following a review of the evaluation, the Committee
recommended that Medsafe should provide a response to the questions posed by the reviewer at a future meeting.

The Committee will be provided with an update on the progress of Medsafe's response.

6

Applications for consent to distribute a new medicine under section 20 of the Medicines
Act 1981 (referred by the Minister of Health under section 22(2))

6.1

Tresivac MMR vaccine, powder for injection with diluent (TT50-9138)

Te Arai BioFarma Limited

Tresivac is a MMR vaccine containing live measles, mumps and rubella viruses. The measles and mumps virus
strains used differ from those products currently registered in New Zealand. Vaccination with a MMR vaccine
forms part of the New Zealand immunisation schedule at age 15 months and four years.

The application has undergone two rounds of 'Requests for Information' in accordance with Medsafe's standard
evaluation processes and many issues remain unresolved. Medsafe is unable to recommend that the benefits of
using the medicine Tresivac in the prevention of MMR outweigh the risk presented by these unresolved issues.

The application is being referred to the Committee for independent advice as to whether the Minister of Health
should grant consent.

7

Review of evaluation reports

7.1

List of medicines for potential review in 2015

The Committee will be provided with a list of all medicines of which evaluations were concluded in 2014.

The Committee will discuss which medicines should be reviewed (a maximum of eight will be chosen) and by
which member of the Committee. Completed reviews will be brought back to the next meetings in June and September
2015.

8

General business

8.1

New Zealand's domestic regulatory reform

An update will be provided following the announcement that the Australian and New Zealand Governments have
agreed to cease efforts to establish a joint therapeutic products regulator (the Australia New Zealand
Therapeutic Products Agency (ANZTPA)).